Remicade Safety Line (Study P03236)(COMPLETED)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

576 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-08-31

Study Completion Date

2010-12-31

Brief Summary

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The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.

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Detailed Description

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This study used a non-probability sampling method.

Conditions

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Arthritis, Rheumatoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infliximab -Rheumatoid Arthritis Participants

Infliximab

Intervention Type BIOLOGICAL

Patients with active rheumatoid arthritis (RA) confirmed with American College of Rheumatology (ACR) criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of

Infliximab therapy with additional infusions of 5 mg/kg at week 2

Interventions

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Infliximab

Patients with active rheumatoid arthritis (RA) confirmed with American College of Rheumatology (ACR) criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, received Infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of

Infliximab therapy with additional infusions of 5 mg/kg at week 2

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade

Eligibility Criteria

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Inclusion Criteria

* Patients with active rheumatoid arthritis confirmed with adequate clinical response(ACR) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab.